Transcatheter aortic valve implantation with Core Valve: First Indian experience of three high surgical risk patients with severe aortic stenosis

Seth, Ashok; Rastogi, Vishal; Kumar, Vijay; Maqbool, Syed; Mustaqueem, Arif; Sekar, Vashisht

doi:10.1016/j.ihj.2013.06.003

Cited by 5 publications

(5 citation statements)

References 12 publications

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“…The first clinical experience of TAVI in India was in 2012 in an octogenarian lady with a previous history of CABG and a porcelain aorta with severe AS that was left unoperated for 12 years and became the cause of her recurrent heart failure admissions ( 28 ). TAVI procedure is currently done in 30 centres across India out of which 7 centres cater to the maximum cases ( 29 ).…”

Section: Discussionmentioning

confidence: 99%

Transcatheter Aortic Valve Implantation for Severe Bicuspid Aortic Stenosis – 2 Years Follow up Experience From India

Kumar

Sengottuvelu

Singh

et al. 2022

Front. Cardiovasc. Med.

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BackgroundTranscatheter aortic valve implantation (TAVI) is challenging in bicuspid aortic valve (BAV) anatomy. The patients are young, morphological phenotypes are many, calcium burden is high and there are technical challenges for best outcomes. Observational studies and registries are available with favorable data and experiences from around the world sharing methodologies and algorithms for sizing and implantation. We, therefore, analysed our data of procedural and in-hospital outcomes of TAVI in Bicuspid Aortic Valve cases performed at two high volume centres in India and their follow up for two years.Methods and ResultsThe data were collated and analysed from two centres (Fortis Escorts Heart Institute, New Delhi and Apollo Hospitals, Chennai) in India for patients who underwent TAVI in a BAV anatomy. It included a total of 70 cases from 2 centres. All symptomatic severe AS patients more than and equal to 65 years having bicuspid anatomy were included in the study irrespective of their STS score. Patients under 65 years of age were advised TAVI only if they were at high risk for open heart surgery. These patients were followed for a period of 2 years and the data were analysed. Pre TAVI imaging tools utilised were 2D echo, transthoracic echocardiography (TTE), trans oesophageal echocardiography (TEE), and ECG gated multi slice CT (MSCT) scan imaging. MSCT was utilised for confirmation of the anatomy and classifying the morphological type of valve, measuring, and evaluating all anatomic determinants of aortic root complex for planning the procedure and choice of the valve and its size. Sizing in balloon expanding valve (BEV) and self-expanding valve sizing (SEV) were based primarily on annulus area and perimeter, respectively. The SEV used in our study were the Core Valve and Evolut R (Medtronic, United States) and the BEVs included Sapien3 (Edwards Lifesciences, United States) and Myval (Meril Lifesciences, India). The BAV cohort constituted 24.4% of the total 287 TAVI cases, followed up for 2 years. The mean age of these patients was 72 years. The incidence of male patients was 68.57% and female patients was 31.4%. The Sievers type 1 included 78.5%, type 0 were 21.4% of the cases and there was no case of type 2 in the study. The procedural success was to the tune of 98%. Patients with normal left ventricular ejection fraction (LVEF) improved their symptoms class after TAVI and remained so at 2 years follow up. The poor LVEF subset of patients did not have heart failure admissions and also had improvement in their symptom status. The peak-to-peak aortic valve gradient decreased to 0 mmHg at the end of the procedure in most of the cases. The mean pressure gradient (PG) across the new valve ranged between 0 and 15 mmHg and the aortic valve area (AVA) was close to 2 cm2. These numbers were consistent at 2 years follow up. Significant paravalvular leak (PVL) 24.28% was seen immediately after deployment of the valve in heavily calcified anatomy but it reduced to mild or trivial PVL after post-dilation and one patient needed a second valve to treat PVL. No patient had more than mild PVL with either type of valve at the end of the procedure. Permanent pacemaker implantation (PPI) was required in 11.4% of the patients within 24 h to 7 days of the procedure. No one needed a PPI in the 2 year follow up. Coronary occlusion did not happen to any patient. No patient had a disabling stroke. Non-disabling stroke was seen in 10% of cases and mostly in the first week or 30 days of the procedure and the incidence was more with BEV (14%) as compared to SEV (8%). There was one case of valve embolisation after 24 h of the procedure, which needed a surgical valve replacement. There was no case of annular injury or injury to other parts of the aortic root complex. Two cases had access vessel (femoral artery) thrombosis at end of the procedure and a third patient had proglide related residual stenosis. Two cases had acute kidney injury and needed dialysis. There was no major bleeding complication in any patient. Peri procedural mortality occurred in two patients. Valve thrombosis was seen in one patient after 3 months, which was treated with oral anticoagulation. Valve degeneration and failure or infective endocarditis were not seen in any patient.ConclusionThe patients with BAV stenosis who underwent TAVI in this study had good procedural success rates and clinical outcomes. The haemodynamics achieved with both SEV and BEV were good at 2 years. The rates of PVL, PPI, and stroke are similar to that of many other studies and registries. PPI rate and non-disabling stroke incidence appear to be higher similar to many studies done. There was no case of coronary occlusion in the study. Meticulous CT analysis of the aortic root complex, selection of appropriate type and size of the valve, and best implantation practices along with cerebral protection will probably be the key to safer and more successful TAVI in this population.

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Section: Discussionmentioning

confidence: 99%

Transcatheter Aortic Valve Implantation for Severe Bicuspid Aortic Stenosis – 2 Years Follow up Experience From India

Kumar

Sengottuvelu

Singh

et al. 2022

Front. Cardiovasc. Med.

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“…A new self-expandable biological valve (CoreValve) was pioneered by the French cardiac surgeon Professor Jacques Seguin. Following initial implants in patients in India in 2002 ( 16 ), the first human implantation in Europe was performed by Professor Eberhard Grube in Germany in 2005 ( 17 ), followed by a registry study in 25 patients ( 18 ). These procedures were performed with the patient in general anesthesia and with percutaneous extracorporeal femoral-femoral bypass.…”

Section: Tavi From 1989 and Beyondmentioning

confidence: 99%

How Transcatheter Aortic Valve Implantation (TAVI) Was Born: The Struggle for a New Invention

Andersen

2021

Front. Cardiovasc. Med.

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This story is about the invention of transcatheter aortic valve implantation (TAVI), and the people who transformed it from a concept and primitive device to a breakthrough lifesaving treatment for hundreds of thousands of patients with aortic valve stenosis. It is an inspirational example of a new disruptive technology that began with an idea most dismissed. The story describes the ups and downs from idea, design, construction, animal testing, proof-of-concept, scientific publication hurdles, a patent, license agreement, cooperation with several companies, fighting in patent courts in Europe and USA and finally how multinational companies financially bypassed the inventor. It is also a story about the struggles and battles the inventor experienced when injected into a world of lawyers and patent fights. I hope my personal story and journey can provide an inspiration and word of caution for new inventors.

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“…She underwent the first TAVR in India with a 26-mm Medtronic CoreValve through the transfemoral route and was discharged in a healthy condition. Two more patients underwent TAVR in February 2012 with the Medtronic CoreValve, out of which one of them required permanent pacemaker implantation (10). Currently TAVR is being done in around 30 centres across India out of which approximately seven centres are handling the majority of the TAVR load.…”

Section: Status Of Tavr In Indiamentioning

confidence: 99%

Current status of transcatheter aortic valve replacement in India

Gupta

Arora

Qamar

et al. 2020

Cardiovasc Diagn Ther

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Transcatheter aortic valve replacement (TAVR) has proven to be the cornerstone therapy for patients with severe aortic stenosis (AS). India is currently overburdened with AS, both rheumatic and nonrheumatic. Although TAVR has revolutionized the treatment of non-rheumatic AS it does offer a ray of hope for rheumatic AS in future. It is difficult to measure the actual burden of AS in India due to lack of epidemiological studies in this population. Variable estimates have been given indicating a large number of patients eligible for TAVR. Despite its enormous potential, TAVR is still beyond the reach of an average Indian citizen. The progress for TAVR in India remains rather slow with obstacles at multiple levels. These include high costs, lack of coverage by insurance companies, continuous ignorance in government policies, lack of sufficient trained TAVR performing operators and lack of healthcare providers trained in post-TAVR care. Additionally, unique anatomical factors such as smaller body surface area, smaller annulus size, low coronary ostia take-off, smaller calibre of iliac and common femoral arteries pose unique challenges in terms of need for smaller hardware and increased chances of complications. It is crucial that the policy makers and healthcare personnel wake up to the benefits of this innovation and take appropriate steps to ease the dissemination of TAVR across the country.

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Transcatheter aortic valve implantation with Core Valve: First Indian experience of three high surgical risk patients with severe aortic stenosis

Cited by 5 publications

References 12 publications

Transcatheter Aortic Valve Implantation for Severe Bicuspid Aortic Stenosis – 2 Years Follow up Experience From India

Transcatheter Aortic Valve Implantation for Severe Bicuspid Aortic Stenosis – 2 Years Follow up Experience From India

How Transcatheter Aortic Valve Implantation (TAVI) Was Born: The Struggle for a New Invention

Current status of transcatheter aortic valve replacement in India

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